SAGALIX 40 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Sagalix, 10 mg, gastro-resistant hard capsules
3. Sagalix, 20 mg, gastro-resistant hard capsules
4. Sagalix, 40 mg, gastro-resistant hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Sagalix and what is it used for
6. Important information before taking Sagalix
   1. When not to take Sagalix
   2. Warnings and precautions
   3. Children
   4. Sagalix and other medicines
   5. Sagalix with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Sagalix contains sucrose and sodium
7. How to take Sagalix
   1. Use in adults:
   3. Use in children and adolescents
   4. Taking this medicine
   5. What to do if an adult or child has trouble swallowing the capsules
   6. Taking a higher dose of Sagalix than recommended
   7. Missing a dose of Sagalix
   8. Stopping treatment with Sagalix
8. Possible side effects
   1. If you notice any of the following rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Sagalix and contact a doctor immediately:
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
   6. Side effects with unknown frequency (frequency cannot be estimated from the available data)
   7. Reporting side effects
9. How to store Sagalix
10. Package contents and other information
    1. What Sagalix contains
    2. What Sagalix looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Ireland
    7. Romania
    8. Poland
    9. Portugal
    10. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Sagalix, 10 mg, gastro-resistant hard capsules

Sagalix, 20 mg, gastro-resistant hard capsules

Sagalix, 40 mg, gastro-resistant hard capsules

Omeprazole

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sagalix and what is it used for
• 2. Important information before taking Sagalix
• 3. How to take Sagalix
• 4. Possible side effects
• 5. How to store Sagalix
• 6. Package contents and other information

1. What is Sagalix and what is it used for

Sagalix contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". They reduce the amount of acid produced by the stomach.
Sagalix is used to treat the following conditions:
In adults:

• "Gastro-esophageal reflux disease" (GERD). GERD causes stomach acid to flow back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Sagalix may also be used to prevent ulcers from forming if the patient is taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age, with a body weight of 10 kg or more

• "Gastro-esophageal reflux disease" (GERD). GERD causes stomach acid to flow back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• In children, symptoms of this condition may include regurgitation of stomach contents into the mouth (regurgitation, vomiting) and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers infected with bacteria called "Helicobacter pylori". If a child has this disease, the doctor may prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Sagalix

When not to take Sagalix

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If the patient is taking medicines containing nelfinavir (used to treat HIV infection).

Do not take Sagalix if any of the above statements apply to you.
In case of doubts before taking Sagalix, consult a doctor or pharmacist.

Warnings and precautions

Before taking Sagalix, consult a doctor or pharmacist.
Omeprazole has been associated with severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, and acute generalized exanthematous pustulosis (AGEP). If you notice any symptoms related to these severe skin reactions, as described in section 4, stop taking Sagalix and seek medical help immediately.
Sagalix may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Sagalix, consult a doctor immediately:

• Unexplained significant weight loss and difficulty swallowing.
• Abdominal pain or indigestion.
• The patient starts vomiting food or blood.
• The stool is black (melena).
• Severe or persistent diarrhea occurs, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea.
• The patient has severe liver dysfunction.
• A skin reaction has occurred after treatment with a medicine similar to Sagalix, which reduces stomach acid.
• A specific blood test (chromogranin A) is planned.

While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.
In the case of long-term use of Sagalix (more than 1 year), regular medical check-ups are likely to be necessary. During each visit to the doctor, all new and unusual symptoms and circumstances should be reported.
Taking a proton pump inhibitor like Sagalix, especially for a period longer than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If a skin rash occurs, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue Sagalix treatment. Also, remember to report any other side effects, such as joint pain.

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or children with a body weight of less than 10 kg.

Sagalix and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those that can be obtained without a prescription. This is important because Sagalix may affect the way some other medicines work, and some other medicines may affect the way Sagalix works.
Do not take Sagalix if you are taking medicines containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart rhythm disorders)
• Diazepam (used to treat anxiety, to relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, medical monitoring may be necessary at the start or end of Sagalix treatment
• Blood-thinning medicines, such as warfarin or other vitamin K antagonists. Medical monitoring may be necessary at the start or end of Sagalix treatment
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplants)
• St. John's Wort ( Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Erlotinib (used to treat cancer)
• Methotrexate (chemotherapy, a medicine used in high doses to treat cancer) - if you are taking high-dose methotrexate, your doctor may temporarily stop Sagalix treatment

If your doctor has prescribed antibiotics amoxicillin and clarithromycin, as well as Sagalix, to treat ulcers caused by Helicobacter pyloriinfection, it is very important to inform your doctor about all the medicines you are taking.

Sagalix with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole passes into breast milk in nursing mothers, but it is unlikely to affect the baby at therapeutic doses. The doctor will decide whether you can take Sagalix if you are breastfeeding.

Driving and using machines

Sagalix is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and blurred vision (see section 4) may occur. In such cases, do not drive or use machines.

Sagalix contains sucrose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Sagalix

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.
Recommended doses are given below.

Use in adults:

For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor finds that your esophagus has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may recommend taking a dose of 40 mg for another 8 weeks if your esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once a day.
• If your esophagus has not been damaged, the usual dose is 10 mg once a day.

For the treatment of duodenal ulcers(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may recommend taking the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcers do not heal completely, the dose can be increased to 40 mg once a day for 4 weeks.

For the treatment of gastric ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may recommend taking the same dose for another 4 weeks if the ulcers have not yet healed.
• If the ulcers do not heal completely, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

For the treatment of ulcersof the duodenum and stomach caused by NSAIDs(non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once a day for 4-8 weeks.

To prevent duodenal and gastric ulcers, if you are taking NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers caused byHelicobacter pyloriinfection and to prevent their recurrence:

• The recommended dose is 20 mg of Sagalix twice a day for 1 week.
• Your doctor will also prescribe two antibiotics: amoxicillin and (or) clarithromycin and (or) metronidazole.

For the treatment of excessive stomach acidcaused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and decide how long you should take the medicine.

Use in children and adolescents

For the treatment of GERD symptoms, such as heartburn and acid regurgitation:

• Children over 1 year of age and with a body weight of more than 10 kg can take Sagalix. The dose for children depends on the child's body weight, and the doctor will decide on the appropriate dose.

For the treatment of ulcers caused byHelicobacter pyloriinfection and to prevent their recurrence:

• Children over 4 years of age can take Sagalix. The dose for children depends on the child's body weight, and the doctor will decide on the appropriate dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, to the child.

Taking this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is important not to damage the pellets.

What to do if an adult or child has trouble swallowing the capsules

If an adult or child has trouble swallowing the capsules:

• Open the capsules and swallow the contents directly, with half a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes of preparation.
• To ensure that all the medicine is taken, rinse the glass with half a glass of water and drink. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Sagalix than recommended

If you have taken more Sagalix than the dose prescribed by your doctor, contact your doctor or pharmacist immediately.

Missing a dose of Sagalix

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Sagalix

Do not stop taking Sagalix without first consulting your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Sagalix and contact a doctor immediately:

contact a doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blisters or peeling, and possibly blisters in the mouth, eyes, nose, and genitals. These could be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Severe rash, high temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• Red, flaky, widespread rash with blisters under the skin and fever, which may develop into widespread skin peeling. This could be a sign of acute generalized exanthematous pustulosis (AGEP). (rare)
• Yellow skin, dark urine, and tiredness, which could be signs of liver problems. (rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, bloating with gas.
• Nausea (nausea) or vomiting.
• Mild stomach polyps.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling, numbness, drowsiness.
• Feeling of spinning (dizziness).
• Changes in blood tests that check liver function.
• Skin rash, hives, and itchy skin.
• Feeling unwell and lacking energy.

Rare side effects (may affect up to 1 in 1000 people)

• Blood disorders, such as a reduced number of white blood cells or platelets. This may cause weakness, bruising, or make you more likely to get infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Oral thrush.
• Fungal infection, which can affect the intestines and is caused by yeast.
• Hair loss (alopecia).
• Skin rash in areas exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• Changes in blood tests, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy.
• Erythema multiforme.
• Muscle weakness.
• Enlarged breasts in men.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Colitis (leading to diarrhea).
• If you take Sagalix for more than three months, it is possible that the level of magnesium in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or an increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• A skin rash that can occur with joint pain.

Omeprazole can very rarely affect the number of white blood cells, leading to a lack of immunity. If you experience an infection with symptoms such as fever with a severely deteriorated general condition or fever with local infection symptoms, such as neck, throat, or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) with a blood test.
It is essential to inform your doctor that you are taking Sagalix in such cases.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sagalix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle label after "EXP". The expiry date refers to the last day of the month.
Blister pack (PVC/PE/PVDC/Aluminum): Store in a temperature below 25°C; store in the original package to protect from moisture.
HDPE bottles: No special storage precautions for the medicinal product; store the bottle tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sagalix contains

• The active substance of Sagalix is omeprazole. The gastro-resistant hard capsules of Sagalix contain 10 mg, 20 mg, or 40 mg of omeprazole.
• Other ingredients are sucrose, pellets (consisting of cornstarch, sucrose, and purified water), magnesium hydroxide, cornstarch, disodium phosphate, hypromellose 2910 6cP, sodium lauryl sulfate, mannitol, sodium carboxymethylcellulose Type A, talc, titanium dioxide (E171), macrogol 6000, polysorbate 80, and methacrylic acid-ethyl acrylate copolymer (1:1).
• The 10 mg hard gastro-resistant capsules contain:brilliant blue FCF (E133), yellow iron oxide (E172), titanium dioxide (E171), and gelatin.
• The 20 mg hard gastro-resistant capsules contain:indigo carmine (E132), titanium dioxide (E171), and gelatin.
• The 40 mg hard gastro-resistant capsules contain:titanium dioxide (E171), black iron oxide (E172), and gelatin.

What Sagalix looks like and contents of the pack

Gastro-resistant hard capsules, 10 mg: Hard gelatin capsule, approximately 14.3 mm in length, with a green cap and white body, containing white to off-white or cream-colored spherical pellets.
Gastro-resistant hard capsules, 20 mg: Hard gelatin capsule, approximately 14.3 mm in length, with a blue cap and white body, containing white to off-white or cream-colored spherical pellets.
Gastro-resistant hard capsules, 40 mg: Hard gelatin capsule, approximately 15.9 mm in length, with a white cap and gray body, containing white to off-white or cream-colored spherical pellets.
Pack sizes:
Sagalix, 10 mg is available in blister packs of PVC/PE/PVDC/Aluminum containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, and 100 gastro-resistant hard capsules; and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120, and 250 gastro-resistant hard capsules.
Sagalix, 20 mg is available in blister packs of PVC/PE/PVDC/Aluminum containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, and 100 hard gastro-resistant capsules; and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120, and 250 hard gastro-resistant capsules.
Sagalix, 40 mg is available in blister packs of PVC/PE/PVDC/Aluminum containing 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, and 100 hard gastro-resistant capsules; and in HDPE bottles containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, and 120 hard gastro-resistant capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer

Laboratorios Liconsa S.A.
Avda. Miralcampo, No7, Poligono Industrial Miralcampo
19200 Azuqueca De Henares (Guadalajara)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Ireland

Licomep 10 mg hard gastro-resistant capsules
Licomep 20 mg hard gastro-resistant capsules
Licomep 40 mg hard gastro-resistant capsules

Romania

Sagalix 10 mg gastro-resistant capsules
Sagalix 20 mg gastro-resistant capsules
Sagalix 40 mg gastro-resistant capsules

Poland

Sagalix

Portugal

Laumart

Date of last revision of the leaflet: